Study 329: The Data

The text below reproduces the latest page from the Study329.org site. The links mentioned here will become live on the site once Restoring Study 329 is published late Wednesday – early Thursday next week.

In 2004 as part of the resolution of a fraud action taken by New York State, GlaxoSmithKline agreed to post the data from all their studies on the Company Website. They posted lengthy Clinical Study Reports (CSRs) for all the pediatric antidepressant studies (Paxil). They also posted shorter Summary Reports on Avandia and other drugs.

There are two CSRs for Study 329, one for the Acute Phase (528 pages) and one for the Continuation Phase (264 pages).

In January 2012, Peter Doshi noticed that the CSRs for Study 329 referred to a number of Appendices (A to H), but that these were not present. He wrote to New York State’s Attorney General’s Office who contacted GSK. GSK agreed to post Appendices A – G, but Appendix H was posted without content.

The original coding used by GSK was from an obscure, inaccessible coding dictionary. The Study 329 RIAT Team believed that a more modern and widely-used coding system was more appropriate, and so they re-coded all the adverse events.

Originally, GSK posted all Appendices as PDF documents. Eventually, with the exception of Appendix H, GSK did provide the data in electronic form to the team. For the harms of treatment, we had already created our own “live” spreadsheets which contain both GSK’s codes and the RIAT team coding side by side. These can be downloaded and analyzed. Having the data available is important for debating the meaning of observations, challenging approaches taken and spotting errors.

The most difficult challenge lay in getting access to the data in Appendix H. Appendix H contains the individual patient level data in the form of Clinical / Case Report Forms (CRFs). There are roughly 77,000 pages – between 200-300 pages for each of 273 patients. The correspondence with GSK between December 2013 and March 2014 reveals the negotiations that took place to get access to this data. Click here to view the correspondence.

The Adverse Harms Data Spreadsheet re-created by the 329 RIAT Team contains material from Appendix H which gave rise to adverse events not listed in the original Appendix D. To make the data usable, the Study 329 RIAT Team had to create Excel Spreadsheets and re-enter the data.

GSK also granted access “for audit purposes” to Appendix H, the CRFs. Even though all patient names and details were redacted, this access was not in the form of a PDF. It was through a “periscope” – a remote access portal that reached into GSK and allowed Joanna Le Noury to scrutinize the 77,000 pages individually without being able to print or download them. She had to make manual notations for each document.

We used the R environment for statistical computing and graphics for this Study. Under our data access agreement with GSK, we cannot post the data. Consequently, the RIAT team is unable to provide direct access to this data. However, the full efficacy data is available in a PDF format. (See Appendix B, C, & D above)

Comments

Are there sign off notations on each of these CRFs? Is the credential of each reporter known?

What is the level of expertise required by the reporter who reviewed and evaluated the significance of the adverse effects recorded in Appendix H?

The “periscope” you describe as the remote access portal to Appendix H bears a strong resemblance to the restricted access policies imposed by the Juvenile Court here in Boston, with regard to medical records, secured by court order at the request of attorneys representing the family of a young patient who had been declared a “ward of the state,”
Attorneys can view the records in a monitored room in the court house for a prescribed period of time. Attorneys are allowed only legal pads and pens– no electronic devices, for making notations. To further impede this vital process, it is common practice for the medical records to be shuffled out of sequence, then stuffed into as many uncoded boxes as needed to contain up to a year’s worth of medical records. Apparently, there is no law, or established legal guidelines that prohibit such blatant attempts to impede the review process of confidential documents. Institutions who are under scrutiny must take a certain amount of delight in knowing everything == literally everything they can get away with!

Well done David for cutting through the lies, somehow the word lies feels impudent,it doesn’t cover the magnitude of what is being done.
Can anyone tell me if Stewart Hosie MP is worth going to with a claim just asking on behalf of a good friend.

Thank you and your colleagues’ for your relentless pursuit of the whole truth. If this was the way Paxil clinical trial outcomes were handled in the past, was that what gave drug companies tacit approval (freedom from repercussions) to put other similar iterations of these drugs on the market? Is there no end to this? No day of reckoning? No way to compensate people for their destroyed lives? Why is Effexor still on the market? Why is Abilify marketed as a booster drug when the never, ever to begin with antidepressants’ ability to deaden emotions would wear off? Why, why, why?